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RH Genotype Matched Red Cell Transfusions for Patients With Sickle Cell Disease
To determine the feasibility and efficacy of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.
This is a Phase 1/2 trial in patients with Sickle Cell Disease requiring chronic red cell transfusions. RH genotyped donor units will be obtained from the New York Blood Center. Patients will be matched with donor units whose RH genotypes predict no foreign Rh protein exposure to the patient. This will provide red cell matching at a level above the current standard of care (serologic C, E, and K matching). Patients will receive RH matched red cells for the duration of their chronic transfusion therapy or up to three years, whichever is shorter. In the pilot phase, we have determined it is feasible to identify RH matched donor units for the patient's RH genotype for every scheduled transfusion. We will now continue to show feasibility as well as determine efficacy by monitoring Rh alloantibody formation. For subjects with a history of stroke/recurrent transient ischemic attack or other indication who require tight control of Hb S, and RH genotyped blood is not available, standard of care serologic matched blood would be administered rather than delaying transfusion and risking higher Hb S level. For all subjects, standard of care serologic matched blood would be administered rather than delaying transfusion beyond 7 days.
Age
0 - No limit years
Sex
ALL
Healthy Volunteers
No
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Start Date
January 30, 2020
Primary Completion Date
April 1, 2029
Completion Date
October 1, 2029
Last Updated
May 4, 2025
35
ESTIMATED participants
Red cell units that are genotype matched at the RHD and RHCE loci
BIOLOGICAL
Lead Sponsor
Children's Hospital of Philadelphia
Collaborators
NCT02274415
NCT02972138
Data Source & Attribution
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